Improving medication adherence in individuals with bipolar disorder

Effectiveness RCT of Customized Adherence Enhancement

This study is testing a new technology-based approach to help people with bipolar disorder stick to their medication better and improve their overall well-being.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Case Western Reserve University (Academic / other)
• Locations: 3 sites (Cleveland, Ohio and 2 other locations)
• Trial ID: NCT04622150 on ClinicalTrials.gov

What this trial studies

This project aims to enhance medication adherence among individuals with bipolar disorder (BD) through a technology-facilitated approach called Customized Adherence Enhancement (CAE). The study will compare the effectiveness of CAE against enhanced treatment as usual (eTAU) in public mental health care settings, specifically targeting individuals who are poorly adherent and at high risk. Participants will receive tailored interventions that address their specific barriers to adherence, utilizing web and text messaging technology to facilitate engagement. The study will be conducted over six months and aims to improve both medication adherence and functional outcomes for vulnerable populations with BD.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Bipolar Disorder Type I or II who have struggled with medication adherence for at least two years.

Not a fit: Patients who are not experiencing issues with medication adherence or who are unable to participate in psychiatric interviews may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve medication adherence and overall health outcomes for individuals with bipolar disorder.

How similar studies have performed: Previous studies have shown promising results with similar adherence enhancement approaches, but this specific adaptation for public healthcare settings is novel.

Eligibility criteria

Patients receiving care at the Nord Center, MetroHealth system, and other not-for-profit health systems.

Inclusion Criteria:

1. Participants will have a diagnosis of Bipolar Disorder Type I or Type II determined by the Structured Clinical Interview for DSM-5 patient version (SCID-P).
2. Have had BD for at least two years duration
3. Have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer)
4. Yes to either of the following questions:

   1. Do you ever have any trouble taking all of your medications? Or
   2. Do you ever try to cope on your own without medication?
5. a BPRS ≥ 36 or YRMS ≥8 or MADRS ≥8
6. Be able to participate in psychiatric interviews and give written informed consent
7. Have their own cellular phone in order to receive text messages as part of the intervention

Exclusion Criteria:

1. Unable or unwilling to participate in psychiatric interviews. This will include individuals, who may be too psychotic to participate in interviews/rating scales
2. Unable or unwilling to give written, informed consent to study participation
3. Individuals who participated in Phase 1 of the study
4. Children under the age of 18
5. Individuals at high risk for suicide who cannot be safely managed in their current treatment setting

Where this trial is running

Cleveland, Ohio and 2 other locations

• W.O. Walker Center — Cleveland, Ohio, United States (Recruiting)
• MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)
• The Nord Center — Lorain, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Martha Sajatovic, MD — Case Western Reserve University
• Study coordinator: Research Manager

Conditions Bipolar Disorder